Clinical Researches

Clinical Researches

Centre of Clinical Research Excellence (CCRE), at JSS University was approved as a collegium of Clinical Development Services Agency (CDSA)- A DBT, Ministry of Science and Technology, Government of India initiative to facilitate the development of healthcare products for the public health system in 2015. The department started its operations in clinical research training in 2016, and is now fully equipped to initiate clinical trials related operations.

  • Coordinating center for conducting high quality and ethical clinical research / trials as per GCP guidelines.
  • Conduct GCP and other clinical research associated training for clinicians and hospital staff.

CCRE will provide assistance to sponsors as well as PIs in all aspects of clinical trials, right from pre-trial review through study close out, to ensure that the research is being conducted in compliance to GCP guidelines. This will include, but is not limited to:

  • Identifying suitable PI for the trial
  • Sponsor-PI Liaison
  • Pre-site visit co-ordination
  • Eligibility determination
  • EC submission
  • DCGI approval
  • CTRI registration
  • Consent document
  • Preparing SOPs
  • Compliance with sponsor form and IRB guidelines
  • Specimen/ Sample/ Investigational Product coordination
  • Interim data management
  • Audits and Monitoring

The activities highlighted in red will be provided free of cost. Other clinical research activities can be extended to the sponsor on chargeable basis.

JSS Medical College & Hospital is an 1800 bedded facility, providing services in 37 specialties / super-specialties including Medicine, Psychiatry, Pediatrics, Cardiology, Dermatology, Nephrology, Gastroenterology, etc. Along with 55 speciality clinics. Besides the hospital, JSS University also has a Dental College, Pharmacy College, and Faculty of Life Sciences. Moreover, being an academic organization, we have a pool of enthusiastic, research-oriented investigators, to facilitate the conduct of clinical trials. Another highlight of our set up is a dedicated in-house department of Pharmacy Practice within the hospital premises, which specializes in Adverse Event Reporting and Documentation.

Our organization has been a part of several clinical trials to date. As per CTRI records, JSS has been a site for 65 registered trial until May 2017, including observational, interventional, BA/BE as well as Post-marketing studies, spanning a wide range of study areas like mental health disorders (Schizophrenia, Depression), diabetes, heart conditions, vaccines, nutritional supplement, dental trial, etc.

Thus, CCRE has been established with the vision of utilizing all the available resources of the organization to develop it as a state-of-the-art coordination center for GCP compliant conduct of clinical trials. We are now looking to expand our services as a trial site and thus invite sponsors for a unique opportunity to conduct trials at our center. Currently, we are inviting trial applications for:

  • Bioavailability and Bioequivalence studies
  • Biotech Products
  • Global Clinical Trials
  • Local Clinical Trials
  • Medical devices
  • Vaccines